Nittyfor-Crem (Cream) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Works, Private Limited Company (Hungary)

ATC Code

P03AC04 (Permethrin)

Active Substance

Permethrin (Rec.INN registered by WHO)

Dosage Form

Nittyfor-Crem

Cream 1%: fl. 115 ml

Dosage Form, Packaging, and Composition

Cream 1% of orange color, with a specific odor.

Excipients: cosmetic cream with conditioner.

115 ml – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of pediculosis

Pharmacotherapeutic Group

Ectoparasiticide

Pharmacological Action

The pediculicidal agent Nittyfor-Crem is a ready-to-use cream of orange color with a specific odor, which contains 1% permethrin as the active substance.

The agent is highly effective against adult lice, larvae, and nits upon 10 minutes of contact with them.

According to the GOST 12.1.007-76 hazard classification, the agent belongs to class 4 (low-hazard compounds) upon ingestion and application to the skin.

In the recommended application regimen, it does not possess sensitizing, local irritant, or skin-resorptive effects.

The maximum permissible concentration (MPC) of permethrin in the workplace air is 1 mg/m³ (aerosol).

Indications

The agent is intended for external use to eliminate head and pubic lice and their nits in adults and children from 5 years of age in the practice of medical disinsection by professional contingents and by the population at home.

ICD codes

Dosage Regimen

First, wash the hair with a regular shampoo, then rinse with water and dry thoroughly with a towel.

Before using the agent, shake the bottle. Then apply the cream evenly to the hair of the head or hairy parts of the body (in case of pubic pediculosis), rubbing it into the hair roots.

After 10 minutes, rinse the agent off the treated body parts with running warm water using soap or shampoo, rinse the hair with a 5% aqueous solution of acetic acid, and comb with a fine-toothed comb to remove dead insects.

The consumption rate of the cream for head pediculosis is 30-60 g per person depending on the degree of insect infestation, length, and thickness of the hair.

In case of re-infestation, repeat the treatment, but not more than 2 times a month.

Adverse Reactions

If itching, signs of irritation, or rash appear on the skin, the agent should be washed off immediately. If necessary, seek medical help.

Contraindications

It is not recommended to treat children under 5 years of age, pregnant and breastfeeding women, as well as people with various skin diseases, or manifestations of allergy to medical and cosmetic products.

Use in Pregnancy and Lactation

It is not recommended to treat pregnant and breastfeeding women.

Pediatric Use

It is not recommended to treat children under 5 years of age.

Special Precautions

To avoid getting the cream on the mucous membranes of the eyes and nasopharynx, before treating the hair, tie a cotton scarf rolled into a tourniquet around the head (below the hair).

If using contact lenses, remove them before applying the pediculicidal cream.

When working with the agent, protect the skin of the hands with rubber gloves.

Observe personal hygiene rules: do not drink, smoke, or eat during work. Wash hands after work.

Avoid getting the agent in the mouth, eyes, and on the skin!

If the agent gets on the skin and mucous membranes (nose, perineum, and genitals), rinse them thoroughly with warm water.

If the agent gets into the eyes, rinse them with plenty of water or a 2% solution of baking soda.

If irritation of the eye mucous membranes appears, instill a 20% or 30% solution of sodium sulfacyl; if pain occurs, instill a 2% solution of novocaine.

Storage Conditions

Store the agent in a dry, closed, dark, cool storage room at a temperature of 15°-25°C (59°-77°F) away from heat sources and sunlight, separately from cosmetic, medicinal products, and food, in a place inaccessible to children.

Shelf life – 2 years.

Transportation of the agent is allowed by all modes of transport in accordance with the transportation rules in force for each mode of transport and guaranteeing the safety of the agent and packaging.

In an emergency situation with a large spill of the agent, cover it with an absorbent material (sand, earth, sawdust, shavings), then collect it in a container for subsequent disposal.

During cleanup, use personal protective equipment: protective clothing (gown, apron, headscarf, footwear); protect the skin of the hands with rubber gloves.

Environmental protection measures: do not allow the undiluted agent to enter wastewater/surface or groundwater and the sewer system.

Dispensing Status

Approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.